Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 10–11

HOS-086179 · Präparat HOS-083284

Medicinal Product Interactions – Ritonavir with Protease Inhibitors Co-administered Dose of Co- Dose of Medicinal Product AUC Cmin Medicinal Product administered NORVIR Assessed Medicinal (mg) Product (mg) Atazanavir 300 q24h 100 q24h Atazanavir ↑ 86% ↑ 11 fold 1 Atazanavir ↑ 2 fold ↑ 3-7 fold Ritonavir increases the serum levels of atazanavir as a result of CYP3A4 inhibition. Clinical trials confirmed the safety and efficacy of 300 mg atazanavir once daily with ritonavir 100 mg once daily in treatment experienced patients. For further information, physicians should refer to the SmPC for atazanavir. Darunavir 600, single 100 q12h Darunavir ↑ 14 fold Ritonavir increases the serum levels of darunavir as a result of CYP3A inhibition. Darunavir must be given with ritonavir to ensure its therapeutic effect. Ritonavir doses higher than 100 mg twice daily have not been studied with darunavir. For further information, refer to the SmPC for darunavir. Fosamprenavir 700 q12h 100 q12h Amprenavir ↑ 2.4 ↑ 11 fold fold Ritonavir increases the serum levels of amprenavir (from fosamprenavir) as a result of CYP3A4 inhibition. Fosamprenavir must be given with ritonavir to ensure its therapeutic effect. Clinical trials confirmed the safety and efficacy of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily. Ritonavir doses higher than 100 mg twice daily 10  have not been studied with fosamprenavir. For further information, physicians should refer to the SmPC for fosamprenavir. Indinavir 800 100 q12h Indinavir2 ↑ 178% ND q12h Ritonavir ↑ 72% ND Ritonavir increases the serum levels of indinavir as a result of CYP3A4 inhibition. Appropriate doses for this combination, with respect to efficacy and safety, have not been established. Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily. In cases of co-administration of ritonavir (100 mg twice daily) and indinavir (800 mg twice daily) caution is warranted as the risk of nephrolithiasis may be increased. Nelfinavir 1250 100 q12h Nelfinavir ↑ ND q12h 20to39% Ritonavir increases the serum levels of nelfinavir as a result of CYP3A4 inhibition. Appropriate doses for this combination, with respect to efficacy and safety, have not been established. Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily. Tipranavir 500 200 q12h Tipranavir ↑ 11 fold ↑ 29 fold q12h Ritonavir ↓ 40% ND Ritonavir increases the serum levels of tipranavir as a result of CYP3A inhibition. Tipranavir must be given with low dose ritonavir to ensure its therapeutic effect. Doses of ritonavir less than 200 mg twice daily should not be used with tipranavir as they might alter the efficacy of the combination. For further information, physicians should refer to the SmPC for tipranavir. ND: Not determined. 1. Based on cross-study comparison to 400 mg atazanavir once daily alone. 2. Based on cross-study comparison to 800 mg indinavir three times daily alone.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) atazanavir (HOS-086180) nelfinavir (HOS-084520) protease (HOS-085623) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) tipranavir (HOS-086184)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 43

HOS-086399 · Präparat HOS-083284

Co- Dose of Co- Dose of Medicinal Product AUC Cmin administered administered NORVIR Assessed Medicinal Medicinal Product (mg) Product (mg) Atazanavir 300 q24h 100 q24h Atazanavir ↑ 86% ↑ 11 fold 1 Atazanavir ↑ 2 fold ↑ 3-7 fold Ritonavir increases the serum levels of atazanavir as a result of CYP3A4 inhibition. Clinical trials confirmed the safety and efficacy of 300 mg atazanavir once daily with ritonavir 100 mg once daily in treatment experienced patients. For further information, physicians should refer to the SmPC for atazanavir. Darunavir 600, single 100 q12h Darunavir ↑ 14 fold Ritonavir increases the serum levels of darunavir as a result of CYP3A inhibition. Darunavir must be given with ritonavir to ensure its therapeutic effect. Ritonavir doses higher than 100 mg twice daily have not been studied with darunavir. For further information, refer to the SmPC for darunavir. Fosamprenavir 700 q12h 100 q12h Amprenavir ↑ 2.4 ↑ 11 fold fold Ritonavir increases the serum levels of amprenavir (from fosamprenavir) as a result of CYP3A4 inhibition. Fosamprenavir must be given with ritonavir to ensure its therapeutic effect. Clinical trials confirmed the safety and efficacy of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily. Ritonavir doses higher than 100 mg twice daily have not been studied with fosamprenavir. For further information, physicians should refer to the SmPC for fosamprenavir. Indinavir 800 q12h 100 q12h Indinavir2 ↑ 178% ND Ritonavir ↑ 72% ND Ritonavir increases the serum levels of indinavir as a result of CYP3A4 inhibition. Appropriate doses for this combination, with respect to efficacy and safety, have not been established. Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily. In cases of co-administration of ritonavir (100 mg twice daily) and indinavir (800 mg twice daily) caution is warranted as the risk of nephrolithiasis may be increased. Nelfinavir 1250 q12h 100 q12h Nelfinavir ↑ ND 20to39% Ritonavir increases the serum levels of nelfinavir as a result of CYP3A4 inhibition. Appropriate doses for this combination, with respect to efficacy and safety, have not been established. Minimal benefit of ritonavir-mediated pharmacokinetic enhancement is achieved with doses higher than 100 mg twice daily. Tipranavir 500 q12h 200 Tipranavir ↑ 11 fold ↑ 29 fold q12h Ritonavir ↓ 40% ND Ritonavir increases the serum levels of tipranavir as a result of CYP3A inhibition. Tipranavir must be given with low dose ritonavir to ensure its therapeutic effect. Doses of ritonavir less than 200 mg twice daily should not be used with tipranavir as they might alter the efficacy of the combination. For further information, physicians should refer to the SmPC for tipranavir. ND: Not determined.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) atazanavir (HOS-086180) nelfinavir (HOS-084520) amprenavir (HOS-086183) darunavir (HOS-086181) fosamprenavir (HOS-086182) tipranavir (HOS-086184)

Wechselwirkungen · Viramune

Viramune 200 mg tablets · Abschnitt 4.5 · PDF-Seite 11

HOS-088105 · Präparat HOS-083615

Tipranavir/ritonavir No specific drug-drug interaction Tipranavir and Viramune can be 500/200 mg BID study has been performed. co-administered without dose The limited data available from a adjustments. phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521) tipranavir (HOS-086184)

Wechselwirkungen · Viramune

Viramune 50 mg/5 mL oral suspension · Abschnitt 4.5 · PDF-Seite 36

HOS-088203 · Präparat HOS-083615

Tipranavir/ritonavir No specific drug-drug interaction Tipranavir and Viramune can be 500/200 mg BID study has been performed. co-administered without dose The limited data available from a adjustments. phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521) tipranavir (HOS-086184)

Wechselwirkungen · Viramune

Viramune 400 mg prolonged-release tablets · Abschnitt 4.5 · PDF-Seite 61

HOS-088296 · Präparat HOS-083615

Tipranavir/ritonavir No specific drug-drug interaction Tipranavir and Viramune can be 500/200 mg BID study has been performed. co-administered without dose The limited data available from a adjustments. phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521) tipranavir (HOS-086184)

Wechselwirkungen · Kaletra

Kaletra (80 mg + 20 mg) / ml oral solution · Abschnitt 4.5 · PDF-Seite 12

HOS-108852 · Präparat HOS-093083

(inhibition of CYP3A enzymes) HIV CCR5 – antagonist Maraviroc Maraviroc: The dose of maraviroc should be AUC: ↑ 295% decreased to 150 mg twice daily Cmax: ↑ 97% during co-administration with Due to CYP3A inhibition by Kaletra 400/100 mg twice daily. lopinavir/ritonavir. Integrase inhibitor Raltegravir Raltegravir: No dose adjustment necessary AUC: ↔ Cmax: ↔ C12: ↓ 30% Lopinavir: ↔ Co-administration with other HIV protease inhibitors (PIs) According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended. Fosamprenavir/ ritonavir Fosamprenavir: Co-administration of increased (700/100 mg BID) Amprenavir concentrations are doses of fosamprenavir (1400 mg significantly reduced. BID) with Kaletra oral solution (Lopinavir/ritonavir (533/133 mg BID) to protease 400/100 mg BID) inhibitor-experienced patients resulted in a higher incidence of or gastrointestinal adverse events and elevations in triglycerides with the Fosamprenavir (1400 mg combination regimen without BID) increases in virological efficacy, when compared with standard (Lopinavir/ritonavir doses of fosamprenavir/ritonavir. 533/133 mg BID) Concomitant administration of these medicinal products is not recommended. Tipranavir/ritonavir Lopinavir: Concomitant administration of (500/100 mg BID) AUC: ↓ 55% these medicinal products is not Cmin: ↓ 70% recommended. Cmax: ↓ 47% Acid reducing agents Omeprazole (40 mg QD) Omeprazole: ↔ No dose adjustment necessary

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): protease (HOS-085623) maraviroc (HOS-086186) amprenavir (HOS-086183) raltegravir (HOS-086187) fosamprenavir (HOS-086182) tipranavir (HOS-086184) omeprazole (HOS-085912)

Wechselwirkungen · Kaletra

Kaletra 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 48–49

HOS-109005 · Präparat HOS-093083

48 (Lopinavir/ritonavir resulted in a higher incidence of 400/100 mg BID) gastrointestinal adverse events and elevations in triglycerides with the or combination regimen without increases in virological efficacy, Fosamprenavir when compared with standard doses (1400 mg BID) of fosamprenavir/ritonavir. Concomitant administration of these (Lopinavir/ritonavir medicinal products is not 533/133 mg BID) recommended. Kaletra must not be administered once daily in combination with amprenavir. Tipranavir/ritonavir Lopinavir: Concomitant administration of these (500/100 mg BID) AUC: ↓ 55% medicinal products is not Cmin: ↓ 70% recommended. Cmax: ↓ 47% Acid reducing agents Omeprazole (40 mg Omeprazole: ↔ No dose adjustment necessary QD) Lopinavir: ↔ Ranitidine (150 mg Ranitidine: ↔ No dose adjustment necessary single dose) Alpha1 adrenoreceptor antagonist Alfuzosin Alfuzosin: Concomitant administration of Due to CYP3A inhibition by Kaletra and alfuzosin is contra- lopinavir/ritonavir, concentrations indicated (see section 4.3) as of alfuzosin are expected to alfuzosin-related toxicity, including increase. hypotension, may be increased. Analgesics Fentanyl Fentanyl: Careful monitoring of adverse effects Increased risk of side-effects (notably respiratory depression but (respiratory depression, sedation) also sedation) is recommended when due to higher plasma fentanyl is concomitantly concentrations because of administered with Kaletra. CYP3A4 inhibition by lopinavir/ritonavir. Antianginal Ranolazine Due to CYP3A inhibition by The concomitant administration of lopinavir/ritonavir, concentrations Kaletra and ranolazine is of ranolazine are expected to contraindicated (see section 4.3). increase.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfuzosin (HOS-086139) amprenavir (HOS-086183) ranitidine (HOS-085660) fentanyl (HOS-086196) fosamprenavir (HOS-086182) ranolazine (HOS-086141) tipranavir (HOS-086184) omeprazole (HOS-085912)

Wechselwirkungen · Kaletra

Kaletra 100 mg/25 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 83–84

HOS-109078 · Präparat HOS-093083

83 Maraviroc Maraviroc: The dose of maraviroc should be AUC: ↑ 295% decreased to 150 mg twice daily Cmax: ↑ 97% during co-administration with Due to CYP3A inhibition by Kaletra 400/100 mg twice daily. lopinavir/ritonavir. Integrase inhibitor Raltegravir Raltegravir: No dose adjustment necessary AUC: ↔ Cmax: ↔ C12: ↓ 30% Lopinavir: ↔ Co-administration with other HIV protease inhibitors (PIs) According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended. Fosamprenavir/ Fosamprenavir: Co-administration of increased ritonavir (700/100 mg Amprenavir concentrations are doses of fosamprenavir (1400 mg BID) significantly reduced. BID) with Kaletra oral solution (533/133 mg BID) to protease (Lopinavir/ritonavir inhibitor-experienced patients 400/100 mg BID) resulted in a higher incidence of gastrointestinal adverse events and or elevations in triglycerides with the combination regimen without Fosamprenavir increases in virological efficacy, (1400 mg BID) when compared with standard doses of fosamprenavir/ritonavir. (Lopinavir/ritonavir Concomitant administration of these 533/133 mg BID) medicinal products is not recommended. Kaletra must not be administered once daily in combination with amprenavir. Tipranavir/ritonavir Lopinavir: Concomitant administration of these (500/100 mg BID) AUC: ↓ 55% medicinal products is not Cmin: ↓ 70% recommended. Cmax: ↓ 47% Acid reducing agents Omeprazole (40 mg Omeprazole: ↔ No dose adjustment necessary QD) Lopinavir: ↔ Ranitidine (150 mg Ranitidine: ↔ No dose adjustment necessary single dose) Alpha1 adrenoreceptor antagonist Alfuzosin Alfuzosin: Concomitant administration of Due to CYP3A inhibition by Kaletra and alfuzosin is contra- lopinavir/ritonavir, concentrations indicated (see section 4.3) as of alfuzosin are expected to alfuzosin-related toxicity, including increase. hypotension, may be increased.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): alfuzosin (HOS-086139) protease (HOS-085623) maraviroc (HOS-086186) amprenavir (HOS-086183) ranitidine (HOS-085660) raltegravir (HOS-086187) fosamprenavir (HOS-086182) tipranavir (HOS-086184) omeprazole (HOS-085912)

Gegenanzeigen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.3 · PDF-Seite 3

HOS-114793 · Präparat HOS-094169

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.3 · PDF-Seite 3

HOS-114794 · Präparat HOS-094169

Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.3 · PDF-Seite 3–4

HOS-114795 · Präparat HOS-094169

3 Combination of rifampicin with Aptivus with concomitant low dose ritonavir is contraindicated (see section 4.5).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521)

Gegenanzeigen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-114796 · Präparat HOS-094169

Herbal preparations containing St John’s wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir (see section 4.5).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-114797 · Präparat HOS-094169

Co-administration of Aptivus with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These active substances include antiarrhythmics (such as amiodarone, bepridil, quinidine), antihistamines (such as astemizole, terfenadine), ergot derivatives (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (such as cisapride), antipsychotics (such as pimozide, sertindole, quetiapine, lurasidone), sedatives/hypnotics (such as orally administered midazolam and triazolam) and HMG-CoA reductase inhibitors (such as simvastatin and lovastatin) (see section 4.5). Also the use of the alpha-1 adrenoceptor antagonist alfuzosin, and sildenafil when used for the treatment of pulmonary arterial hypertension. In addition, co-administration of Aptivus with low dose ritonavir, and medicinal products that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide, propafenone and metoprolol given in heart failure (see section 4.5).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sertindole (HOS-085601) quetiapine (HOS-086150) alfuzosin (HOS-086139) methylergonovine (HOS-086155) propafenone (HOS-084530) cisapride (HOS-085610) lovastatin (HOS-086157) flecainide (HOS-086203) bepridil (HOS-085612) simvastatin (HOS-086158) quinidine (HOS-085593) pimozide (HOS-085600) astemizole (HOS-085608) sildenafil (HOS-086162) ergotamine (HOS-086154) ritonavir (HOS-084521) amiodarone (HOS-085596) terfenadine (HOS-085607) lurasidone (HOS-086148) ergonovine (HOS-086153) metoprolol (HOS-090094) triazolam (HOS-086168) dihydroergotamine (HOS-086152) midazolam (HOS-086167)

Gegenanzeigen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.3 · PDF-Seite 4

HOS-114798 · Präparat HOS-094169

Co-administration of colchicine with Aptivus/ritonavir in patients with renal or hepatic impairment (see section 4.5).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): colchicine (HOS-086147) ritonavir (HOS-084521)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-114799 · Präparat HOS-094169

The interaction profile of Aptivus, co-administered with low dose ritonavir, is complex and requires special attention in particular in combination with other antiretroviral agents.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-114800 · Präparat HOS-094169

Interaction studies have only been performed in adults.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-114801 · Präparat HOS-094169

Metabolic profile of tipranavir Tipranavir is a substrate, an inducer and an inhibitor of cytochrome P450 CYP3A. When co- administered with ritonavir at the recommended dosage (see section 4.2) there is a net inhibition of P450 CYP3A. Co-administration of Aptivus and low dose ritonavir with agents primarily metabolised by CYP3A may result in changed plasma concentrations of tipranavir or the other agents, which could alter their therapeutic and undesirable effects (see list and details of considered agents, below). Agents that are contraindicated specifically due to the expected magnitude of interaction and potential for serious adverse reactions are detailed in this section, and listed in section 4.3.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-114802 · Präparat HOS-094169

A cocktail study was conducted in 16 healthy volunteers with twice-daily 500 mg tipranavir with 200 mg ritonavir capsule administration for 10 days to assess the net effect on the activity of hepatic CYP 1A2 (caffeine), 2C9 (warfarin), 2D6 (dextromethorphan), both intestinal/hepatic CYP 3A4 (midazolam) and P-glycoprotein (P-gp) (digoxin). At steady state, there was a significant induction of CYP 1A2 and a slight induction on CYP 2C9. Potent inhibition of CYP 2D6 and both hepatic and intestinal CYP 3A4 activities were observed. P-gp activity is significantly inhibited after the first dose, but there was a slight induction at steady state. Practical recommendations deriving from this study are displayed below.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): digoxin (HOS-086172) caffeine (HOS-085902) ritonavir (HOS-084521) dextromethorphan (HOS-109265) warfarin (HOS-085950) midazolam (HOS-086167)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 8

HOS-114803 · Präparat HOS-094169

Studies in human liver microsomes indicated tipranavir is an inhibitor of CYP 1A2, CYP 2C9, CYP 2C19 and CYP 2D6. The potential net effect of tipranavir with ritonavir on CYP 2D6 is inhibition, because ritonavir is also a CYP 2D6 inhibitor. The in vivo net effect of tipranavir with ritonavir on CYP 1A2, CYP 2C9 and CYP 2C19, indicates, through a preliminary study, an inducing potential of tipranavir with ritonavir on CYP1A2 and, to a lesser extent, on CYP2C9 and P-gp after several days of treatment. Data are not available to indicate whether tipranavir inhibits or induces glucuronosyl transferases.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): ritonavir (HOS-084521)

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 8–9

HOS-114804 · Präparat HOS-094169

8 In vitro studies show that tipranavir is a substrate and also an inhibitor of P-gp.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.